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Clinical Trials Manager

Full/Part Time: Full Time
Location/Affiliates: The Mount Sinai Hospital
Department: 831 - Medicine Administrat
Requisition Number: 13-1596406

Job Description:

Summary:

* Review of industry sponsored research protocols to ensure study feasibility and practicality. Working closely with Clinical Director, provide guidance to divisions regarding the potential for competing research trials, feasibility of enrollment and potential contracts and budget issues;

* Resolve research protocol specific issues with institutional review committees including the IRB (Program for the Protection of Human Subjects), CRC (Clinical Research Center), PRMC (Protocol Review and Monitoring Committee), CRC (Clinical Research Center) Board and pharmaceuticals companies regarding specific projects including budgets and contracts;

* Initiates and participates in staff recruitment and retention activities for regulatory staff and clinical research coordinator positions within all 11 Divisions of DOM;

* Working directly with Director of Finance for DOM, supervise CTO financial analyst to assure appropriate tracking and monitoring of finances for CTO studies;

* Maximizing efficiency of all CTO staff; restructuring as necessary;

* Train or monitor training of all incoming CTO staff;

* Approves time/effort utilization and productivity of all members.

* Reviews and approves performance appraisal of research and administrative staff;

* Directs day-to-day administrative operations.

* Establish and implements operational policies and procedures to ensure compliance with institutional and federal guidelines as well as regulatory agency standards.

Specific Tasks:

- Manage and track effort for Clinical Research Coordinators across all projects managed through the CTO office

- Working with HR, oversee the hiring process of all new CTO staff

- Working with Clinical Medical Director with annual performance appraisals.

- Analyze monthly reports from CTO database to track and assess volume of studies handled by CTO Regulatory Team. Report should be provided to Clinical Director to assess volume of studies handled by each Regulatory Affairs Coordinator.

- Assists with continuing to develop CTO SOPs for staff and faculty who work with CTO.

- Work with faculty practice leadership to ensure implementation and staff training of CTO SOPs

Job Qualifications:

Must have knowledge and understanding of FDA regulations including CFR (Code of Federal Regulations) and ICH guidelines (International Conference on Harmonisation), OHRP (Office for Human Research Protections and IRB (Institutional Review Board) processes.

Education/Training:

4 to 5 years of progressive clinical research experience in research and regulatory areas strongly preferred.

Mount Sinai Medical Center is an equal opportunity/affirmative action employer. We recognize the power and importance of a diverse employee population and strongly encourage applicants with various experiences and backgrounds. Mount Sinai Medical Center--An EEO/AA-D/V Employer.

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